Trial Search Results

Donor Regulatory T Cells in Treating Patients With Visceral Acute Graft-versus-Host Disease After Stem Cell Transplant

This phase I trial studies the side effects and best dose of donor regulatory T cells in treating patients with graft-versus-host disease affecting the liver or gastrointestinal organs (visceral) within 100 days (acute) after undergoing a stem cell transplant. Graft-versus-host disease occurs when donor immune cells infused in a stem cell transplant attack the gut, skin, liver, or other organ systems of the patient. Regulatory T cells are a type of immune cell that may be able to reduce the attack of the donor's immune cells on the patient's normal cells and help treat graft-vs-host disease.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Everett Meyer

Collaborator: National Cancer Institute (NCI)


  • Biological: donor regulatory T lymphocytes
  • Other: laboratory biomarker analysis


Phase 1


Inclusion Criteria:

   - Visceral aGVHD defined as: at least stage III/IV acute liver or stage II/III
   gastrointestinal (GI) GVHD by clinical criteria and/or GI and/or liver biopsy
   confirmation showing no alternative explanation for symptoms of GVHD

   - Ability to understand and willingness to sign a written informed consent form

   - Must have a 7/8 or 8/8 or haploidentical related donor matched at the human leukocyte
   antigen (HLA)-A, B, C, DRB1 who was evaluated and provided the donor transplant graft

   - Myeloablative or non-myeloablative allogeneic hematopoietic cell transplantation

   - Karnofsky performance status >= 50

   - DONOR: Age >= 18 to =< 77 years old

   - DONOR: Karnofsky performance status of >= 70% defined by institutional standards

   - DONOR: Must be the same sibling donor from whom the recipient's blood and marrow graft
   was collected for the original allogeneic transplant that is HLA 7/8 or 8/8 or
   haploidentical matched at the HLA-A, B, C, and DRB1

   - DONOR: Serologies for human immunodeficiency virus (HIV) antigen (Ag), HIV 1 and HIV 2
   antibody (Ab), human T-cell lymphotropic virus (HTLV) 1 and HTLV 2 Ab, hepatitis B
   surface antigen (sAg) or polymerase chain reaction (PCR)+, or hepatitis C Ab or PCR+,
   syphilis (Treponema) screen and HIV 1 and hepatitis C by NAT (nucleic acid testing)
   have been collected prior to apheresis

   - DONOR: Female donors of child-bearing potential must have a negative serum or urine
   beta-human chorionic gonadotropin (HCG) test within two weeks of apheresis

   - DONOR: Capable of undergoing leukapheresis, have adequate venous access, and be
   willing to undergo insertion of a central catheter should leukapheresis via peripheral
   vein be inadequate

   - DONOR: Donor selection will be in compliance with 21 Code of Federal Regulations (CFR)

Exclusion Criteria:

   - Uncontrolled infections not responsive to antimicrobial therapy requiring intensive
   critical care

   - Progressive malignant disease, including post-transplant lymphoproliferative disease
   unresponsive to therapy

   - Cytomegalovirus colitis or enteritis as defined by cytomegalovirus (CMV) shell vial or
   culture positivity from endoscopic biopsy the discretion of the treating physician
   based upon PCR positivity, clinical presentation and histology

   - Respiratory insufficiency with oxygen requirement > 4 L nasal cannula

   - Multi-organ failure

   - DONOR: Evidence of active infection or viral hepatitis

   - DONOR: HIV positive

   - DONOR: Pregnant donor

   - DONOR: Factors which place the donor at increased risk for complications from

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting